Abata Therapeutics Announces First Development Candidate ABA-101, a Novel Treg Cell Therapy for the Treatment of Progressive Multiple Sclerosis

BOSTON–(BUSINESS WIRE). the potential to benefit 45,000 progressive multiple sclerosis (MS) patients in the United States who currently have no treatment options.

“The progressive pathology of MS has not been effectively treated because existing therapies fail to address the CNS compartmentalized inflammation that drives this aspect of the disease,” said Richard M. Ransohoff, MD, co-founder and chief medical officer of Abata and Venture- Partner at Third Rock Ventures. “Our approach of harnessing the natural role of Tregs in the immune system allows us to elucidate complex inflammatory mechanisms, bringing new hope to patients without treatment options. Our work to date on the development of ABA-101 validates our approach to using TCR-targeted Treg therapies to treat autoimmune diseases. We look forward to working with our new CSO, Ellen Cahir-McFarland, to translate the science behind ABA-101 into clinical trials in the first half of 2024.”

“Since our inception, we have had an intense focus on advancing transformative therapies for people living with autoimmune diseases. We believe our Treg product engine has produced a candidate in ABA-101 that is truly differentiated and can have significant benefit for people living with progressive MS,” said Samantha Singer, MS, MBA, President and Chief Executive Officer of Abata. “ABA-101 uses a TCR to target our product to the site of ongoing pathology and provide the potential for a robust, highly durable effect. Working with our partners at ElevateBio BaseCamp, we quickly established a basic manufacturing process in less than a year, demonstrating that we can successfully develop and scale up Tregs for use as therapies. Overall, this work gives us great confidence not only in our ABA-101 program, but also in our additional programs in type 1 diabetes and inclusion body myositis.”

“At ElevateBio, we love collaborating with scientific innovators like Abata and helping them advance their novel cell and gene therapies,” said Michael Paglia, MS, Chief Operating Officer, ElevateBio BaseCamp. “It has been a pleasure working with the Abata team and developing and refining a manufacturing process that will allow them to scale up Tregs engineered with an antigen-specific TCR with yields that support the clinical development of ABA-101 and as a template for.” their future programs serve. We look forward to the further partnership.”

The hypothesis for ABA-101 as a Treg treatment for progressive MS is well established in the scientific literature. Single-cell data link chronically active lesions in patients with the adaptive immune system, raising the possibility that a Treg may have a therapeutic effect in progressive MS. In addition, EAE (experimental autoimmune encephalomyelitis) mouse studies show evidence of biology, including TCR-Treg transport, persistence, biological activity and suppression of inflammation – all critical elements for successful treatment. Additional non-clinical studies support Tregs’ Role in myelin repair, another potential benefit of the approach. Abata will use MRI to select patients for enrollment in clinical trials, as chronic active lesions (identifiable by MRI) correlate with disease worsening in progressive MS natural history studies.

About ABA-101 and progressive multiple sclerosis

ABA-101 is Abata’s autologous Treg therapy in development for the treatment of progressive MS. It is intended for MS patients with non-relapsing progressive disease who have a genetic haplotype DRB1*15:01 and in whom imaging evidence of persistent inflammatory tissue injury has been observed – an estimated patient population of approximately 45,000 in the US today. ABA-101 is produced by minimally manipulating a patient’s own Tregs to express a TCR that specifically recognizes immunogenic myelin fragments in the CNS – an approach that offers a potentially strong safety profile and highly localized anti-inflammatory effects at the disease site. in vitroABA-101 demonstrated antigen-specific, dose-dependent Treg functionality, anti-inflammatory cytokine production, and suppression of inflammatory factor (T-cell-derived cytokine) production. ABA-101 retains its Treg phenotype even under inflammatory conditions.

About Abata Therapeutics

Abata Therapeutics is focused on translating regulatory T cell (Treg) biology into transformative medicines for patients with severe autoimmune and inflammatory diseases. Founded by pioneers in Treg biology, TCR and antigen discovery, disease pathogenesis, and molecular and imaging biomarkers, Abata has developed a differentiated product engine to create engineered Treg cell therapies that are tissue-specific, robust, and long-lived. In addition to its leading program in progressive MS, Abata has programs in type 1 diabetes and inclusion body myositis – two other tissue-specific autoimmune diseases with significant unmet needs and a strong rationale for Abata’s Treg approach. The company was founded in 2021 by Third Rock Ventures with participation from a diverse consortium of investors including ElevateBio, Lightspeed Venture Partners, Invus, Samsara BioCapital and the JDRF T1D Fund. Abata is based in Cambridge, Mass. Please visit abatatx.com or follow us Twitter or LinkedIn for more information.

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